Associate CMC Regulatory Sciences Specialist
Rensselaer, NY - Posted on: Thursday 08/25/16
Requisition Number: 7563BR
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for gathering input and data in order to write internal scientific reports and documents for pharmaceutical regulatory submissions.
Essential Duties and Responsibilities include, but are not limited to, the following:
• May prepare or assist with the preparation of a variety of documents to support all phases of clinical drug development. May be responsible for review and revision of product lifecycle documents including, but not limited to, SOPs, validation protocols and reports, and process development reports.
• Rewrites various sources of information into a uniform style and language for regulatory compliance, and assists in developing documentation for instructional, descriptive, reference, and/or informational purposes.
• Collaborates with research and development and manufacturing personnel in the preparation and review of documents; providing feedback on format and content and guidance in general. Keeps management and others informed on progress of documents.
• Works with regulatory contacts on the preparation of CMC sections of new drug submissions, amendments and other regulatory documents for US, Canada, and other international health authorities.
Knowledge and Skills:
• Excellent written and verbal communication skills
• Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a high level of attention to detail is a must
• Knowledge of biopharmaceutical development, testing or manufacturing preferred
• Strong skills in planning, critical thinking, and problem-solving preferred
Education and Experience:
• BS/BA in a scientific discipline required along with at least 2 years of relevant experience in the biopharmaceutical industry
• Experience in Microsoft® programs (Word, Excel, PowerPoint), Adobe Acrobat, templates and controlled EDMS systems is preferred
• Experience with statistical analysis a plus
Title level (Associate Specialist or Specialist) will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Apply directly to careers.regeneron.com and search the requisition # 7563BR.